Reducing Particulate Matter-associated Cardiovascular Health Effects for Seniors

Cardiometabolic Health Clinical Trial

— RAPIDS2-Ypsi  

Official title:

Reducing Particulate Matter-associated Cardiovascular Health Effects for Seniors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04103346
• Other study ID #: HUM00156608
• Secondary ID: 2R01NR014484-06
• Status: Recruiting
• Phase: N/A
• Start date: February 24, 2020
• Est. completion date: June 1, 2025

Study information

• Verified date: April 2024
• Source: University of Michigan
• Contact: Robert Bard
• Phone: 734-615-4907
• Email: bbard[@]umich.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Exposure to fine particulate matter (PM2.5) air pollution is an established risk factor for cardiovascular (CV) morbidity.

Description:

This is a randomized double-blind placebo-controlled (sham filtration) crossover trial comparing the effectiveness bedroom-only portable indoor air filtration units [AFUs] to reduce personal PM2.5 exposures and improve cardiometabolic health. The health benefits (primary outcome: resting BP) will be evaluated over acute (4-day) and long-term (4-week) periods in 50 nonsmoking elderly adults living in a senior facility impacted by near-roadway pollutants.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 55
• Est. completion date: June 1, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• Nonsmoker
• =60 years old
• residing in Carpenter Place Apartments

Exclusion Criteria:

• Active cigarette smoker
• daily secondhand smoke exposure (self-report)
• any CV event (myocardial infarction, stroke, heart failure, revascularization) in the past 3 months
• unstable CV condition or risk factor (uncontrolled diabetes, class 3-4 angina or heart failure) or any medical condition that would place the participant at risk from participation or jeopardize study integrity (per investigators)
• expected overnight travel outside their apartment during the 14-week study period
• unable to provide informed consent
• lung disease requiring oxygen
• renal dialysis
• cancer receiving active treatment or chemotherapy
• severe uncontrolled high BP =160/100 mm Hg or SBP<115 mm Hg.
• CV medication change in the prior month. If participants are on medications for high BP, diabetes, or a CV condition, they will need to have stable therapy during the prior month with no planned changes during the study period.

Related Conditions & MeSH terms

• Cardiometabolic Health

Intervention

Other:
• air filtration with air purifier with hepa filter
long-term (4 week) air filtration with the Holmes HAP8650B-NU-1 air purifier in the residence of low-income seniors impacted by roadway pollutants.
• sham
air purifier running with air filter removed

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (3)

Lead Sponsor	Collaborator
University of Michigan	Michigan State University, National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Systolic Blood Pressure	Blood pressure taken in the morning (mm Hg)	4 weeks
Secondary	Atmospheric particulate matter (pm2.5)	Atmospheric particulate matter is measured in the units of ug/m3 and determined using a portable analyzer (PDR-1500)	4 weeks
Secondary	24-hr Blood Pressure	blood pressure response over 24 hours measured in the units mm Hg.	4 weeks
Secondary	Nocturnal Blood Pressure	Blood pressure taken at night measured in the units mm Hg.	4 weeks
Secondary	Aortic Hemodynamics	Determined using pulse wave analyses of the augmentation index calculated as the height of the reflected wave as a percentage of the total height of the ascending aortic pressure wave.	4 weeks
Secondary	Insulin Sensitivity	To determine the impact of reduced particulate matter on insulin sensitivity, determined by measuring insulin and glucose to calculate the homeostasis model assessment of insulin resistance (HOMA-IR) metric.	4 weeks
Secondary	Evening Blood Pressure	home bp taken in evening measured in the units mm Hg	4 weeks
Secondary	Heart Rate Variability (HRV)	A reduction in time domain, standard deviation of all normal RR intervals (SDNN) will serve as the usual primary outcome for studies, as it has been directly linked with a worse CV prognosis.	4 weeks